MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN LATEX TEMP-SENSING CATHETER

Catalog Number UNKNOWN

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Abdominal Pain (1685); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the facility had experienced 3 safety events where the catheters were not draining appropriately and minimal urine output was noted from the catheters, with patients complaining of abdominal pain, in which a bladder scan resulted in 800ml to more than 1l being present in the bladder.The nurses then had to manipulate the tubing to get the urine to drain.In 1 instance, it was reported that the urine was full of sediment and following flushing the catheter with sterile solution, 850ml had drained.However, the other 2 instances the foleys were not occluded with sediment.It was also routinely observed by the nurses that the catheters were air locking or required manual manipulation each hour to drain urine output into the urometer, whereas previous products drained every hour.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿biological deposits¿.It is unknown whether the device had met relevant specifications.The product was used for diagnostics and treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the unknown latex temp-sensing catheter ifus are found to be adequate based on past reviews.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the facility had experienced 3 safety events where the catheters were not draining appropriately and minimal urine output was noted from the catheters, with patients complaining of abdominal pain, in which a bladder scan resulted in 800ml to more than 1l being present in the bladder.The nurses then had to manipulate the tubing to get the urine to drain.In 1 instance, it was reported that the urine was full of sediment and following flushing the catheter with sterile solution, 850ml had drained.However, the other 2 instances the foleys were not occluded with sediment.It was also routinely observed by the nurses that the catheters were air locking or required manual manipulation each hour to drain urine output into the urometer, whereas previous products drained every hour.No medical intervention was reported.

• Brand Name: UNKNOWN LATEX TEMP-SENSING CATHETER
• Type of Device: UNKNOWN LATEX TEMP-SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13044200
• MDR Text Key: 285485878
• Report Number: 1018233-2021-08211
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other